Recent years have seen a surge in the number patients in West Virginia and throughout the United States who have been harmed by counterfeit drugs or medical devices. In an effort to deal with the counterfeiting issue and other serious public health threats associated with defective medical devices, the U.S. Food & Drug Administration recently announced that it was considering a new rule that would require manufacturers to place a unique identifier on their products.
If approved, the new rule will be phased in over a period of 10 years and will apply to the high risk medical devices such as implants first. In the meantime, however, many Americans will be left asking the question: "What legal options are available to me if I have been harmed by a counterfeit medical device or drug?"
Generally speaking, product liability lawsuits seeking compensation for injuries and other losses caused by a defective medical device can be brought against any party in the supply chain -- manufacturers, distributors and retail sellers included.
An example of how this works in real life is currently unfolding in Illinois, where the medical supply company Medline has been sued by 18 patients thus far in connection with a batch of counterfeit surgical mesh.
Medline reportedly purchased the counterfeit mesh from Ram Medical (a different medical supply company), which said the products had been manufactured by New Jersey-based industry giant C.R. Bard. As it turns out, the surgical mesh Medline purchased from Ram had actually been manufactured by a company in India and was neither sterile nor free of defects.
Patients harmed as a result of receiving this dangerous and defective medical device during surgical procedures are alleging that both distributors were negligent in failing to determine if the mesh was sterile and free from defects.
Source: Crain's Chicago Business, "Medline faces slew of lawsuits over counterfeit medical product," Kristen Schorsch, July 24, 2012